Implantable prosthesis

ABSTRACT

An implantable prosthesis for repairing an anatomical defect, such as a tissue or muscle wall hernia, including an umbilical hernia, and for preventing the occurrence of a hernia at a small opening or weakness in a tissue or muscle wall, such as at a puncture tract opening remaining after completion of a laparoscopic procedure. The prosthesis includes a patch for covering or extending across the opening or weakness. At least one tether, such as a strap, extends from the patch and may be manipulated to position and/or to secure the patch relative to the opening or weakness in the tissue or muscle wall. The tether may be configured to extend through the defect and outside a patient&#39;s body for positioning and/or manipulating the patch from a location outside the body. A support member may be arranged in or on the patch to help deploy the patch at the surgical site and/or help inhibit collapse or buckling of the patch.

This application is a continuation of U.S. application Ser. No.11/508,447, filed Aug. 23, 2006, which is a continuation of U.S.application Ser. No. 10/212,006, filed Aug. 2, 2002.

FIELD OF THE INVENTION

The present invention relates to an implantable prosthesis and, moreparticularly, to a prosthesis for repairing or augmenting openingsand/or weaknesses in a soft tissue or muscle wall.

DISCUSSION OF RELATED ART

Various prosthetic repair materials are known for repairing andreinforcing anatomical defects, such as soft tissue and muscle wallhernias. For example, in connection with a repair of an umbilicalhernia, it is common for a surgeon to place a sheet of prosthetic repairfabric beneath the opening to the defect (“underlay”), above the openingto the defect (“overlay”), or to form the fabric into athree-dimensional shape, such as in the form of a cone or cylinder to“plug” the rupture. It has been recognized that puncture tracts createdin laparoscopic surgery as a passageway for delivering instruments andprostheses to a surgical site may be susceptible to later herniation.Closure of the laparoscopic puncture is typically done with a series ofsutures through the skin and/or underlying tissue and muscle, with orwithout the aid of a fabric-type or other type of prosthesis. Use ofrepair sutures at the puncture wound opening may potentially lead tocomplications of nerve entrapment, vessel injury, or subsequent herniaat the defect site.

It has been suggested for certain procedures to repair an anatomicaldefect using a prosthetic fabric without reapproximating the edges ofthe anatomical defect. For example, U.S. Pat. No. 5,397,331 to Himpenset al. proposes to repair a weakness of the abdominal wall produced by atrocar sheath using a prosthesis that includes a layer of prostheticmaterial for covering the weakness and a resilient stiffener forspreading the layer of material into a planar configuration. A threadextends from the repair device for routing through the trocar sheath sothat a slight pull of the thread draws the repair device against theperitoneum. Upon removal of the trocar sheath, the thread maysubsequently be fastened on the skin surface to hold the prosthesis inposition.

U.S. Pat. No. 5,836,961 to Kieturakis et al. proposes to repair a herniadefect with a patch that includes a disk and a tail that is secured toand extends from the disk. The patch is inserted into a patient usingconventional laparoscopic instruments, and the tail is attached to adistal portion of an inguinal hernia sac. The hernia sac is thenseparated and the pressure of the insufflation gas causes the tail ofthe patch to be pulled upwardly into the inguinal ring to draw the diskagainst the inguinal ring.

It is an object of the present invention to provide an improved methodand prosthesis for repairing and reinforcing soft tissue or musclewalls.

SUMMARY OF THE INVENTION

The present invention relates to an implantable prosthesis for repairingan anatomical defect, such as a tissue or muscle wall hernia, includingan umbilical hernia, and for preventing the occurrence of a hernia at asmall opening or weakness in a tissue or muscle wall, such as at apuncture tract opening remaining after completion of a laparoscopicprocedure.

In one embodiment, an implantable prosthesis includes a body portion ofimplantable, biologically compatible material that is constructed andarranged to cover at least a portion of the tissue or muscle walldefect, and at least one tether extending from the body portion andhaving a cross-section with a width and thickness, the width beinggreater than the thickness. The at least one tether has a length that issufficient to extend through the tissue or muscle wall defect and to beaccessible from outside the patient when the body portion is positionedover the defect. The length of the at least one tether is at least 2.5inches.

In another embodiment, an implantable prosthesis is provided forrepairing an existing or potential tissue or muscle wall defect. Theimplantable prosthesis comprises a body portion of an implantable,biologically compatible material that is constructed and arranged tocover at least a portion of the tissue or muscle wall defect, and firstand second straps extending from the body portion. The first and secondstraps are constructed and arranged to extend through the tissue ormuscle wall defect when the body portion is positioned over the defect.Each of the first and second straps has a cross-section with a width andthickness, the width being greater than the thickness.

In yet another embodiment, an implantable prosthesis is provided forrepairing an existing or potential tissue or muscle wall defect. Theimplantable prosthesis includes a patch of repair fabric that isconstructed and arranged to cover at least a portion of the tissue ormuscle wall defect, a resilient support member disposed on the patch tourge the patch to a planar configuration, and at least one tether ofrepair fabric that is susceptible to tissue and muscle integration. Theat least one tether extends from the patch and is constructed andarranged to extend through the tissue or muscle wall defect when thepatch is positioned over the defect.

In a further embodiment, an implantable prosthesis is provided forrepairing an existing or potential tissue or muscle wall defect. Theimplantable prosthesis comprises a patch of repair fabric that isconstructed and arranged to cover at least a portion of the tissue ormuscle wall defect, a resilient support member disposed on the patch,and at least one strap extending from the patch. The resilient supportmember is constructed and arranged to urge the patch into a planarconfiguration. The at least one strap is constructed and arranged toextend through the tissue or muscle wall defect when the patch ispositioned over the defect. The at least one strap has a cross-sectionwith a width and thickness, the width being greater than the thickness.

In another embodiment, an implantable prosthesis is provided forrepairing an existing or potential tissue or muscle wall defect. Theimplantable prosthesis comprises a body portion of implantable,biologically compatible material that is constructed and arranged tocover at least a portion of the tissue or muscle wall defect, and atleast one tether extending from the body portion and being constructedand arranged to extend through the tissue or muscle wall defect when thebody portion is positioned over the defect. The prosthesis alsocomprises an indicator disposed on the at least one tether at apredetermined location to indicate a position of the body portionrelative to a reference location.

In yet another embodiment, an implantable prosthesis is provided forrepairing an existing or potential tissue or muscle wall defect. Theimplantable prosthesis comprises a patch of repair fabric that isconstructed and arranged to cover at least a portion of the tissue ormuscle wall defect, and at least one tether extending from the patch andbeing constructed and arranged to extend through the tissue or musclewall defect when the patch is positioned over the defect. The patchincludes first and second layers of repair fabric that are joined toeach other to create a pocket therebetween. The patch has an accessopening that is adapted to provide entry into an interior of the pocketto facilitate positioning of the patch over the tissue or muscle walldefect.

In a further embodiment, an implantable prosthesis is provided forrepairing an existing or potential tissue or muscle wall defect. Theimplantable prosthesis comprises at least one layer of repair fabricthat is susceptible to the formation of adhesions with tissue andorgans, and a resilient support member disposed on the at least onelayer of repair fabric. The at least one layer of repair fabric isconstructed and arranged to cover at least a portion of the tissue ormuscle wall defect. The at least one layer of repair fabric has a firstsurface for facing the tissue or muscle wall defect and a second surfacefor facing away from the tissue or muscle wall defect. The resilientsupport member is constructed and arranged to urge the at least onelayer of repair fabric into a planar configuration. The prosthesis alsocomprises first and second straps extending from the first surface ofthe at least one layer of repair fabric. The first and second strapshave a length that is sufficient to extend through the tissue or musclewall defect and outside the patient when the at least one layer ofrepair fabric is positioned over the defect. Each of the first andsecond straps has a cross-section with a width and thickness, the widthbeing greater than the thickness.

In still another embodiment, a method is provided to repair an existingor potential tissue or muscle wall defect in a patient. The methodcomprises providing an implantable prosthesis that includes a patch ofrepair fabric that is constructed and arranged to cover at least aportion of the tissue or muscle wall defect, and at least one strap ofrepair fabric extending from the patch and being constructed andarranged to extend through the tissue or muscle wall defect and protrudeoutside the patient when the patch is positioned over the defect. The atleast one strap has a cross-section with a width and thickness, thewidth being greater than the thickness. The method also comprisesintroducing the patch into the patient; routing the at least one strapto extend through the defect and to a region that is accessible fromoutside the patient; and positioning the patch over the defect.

Various embodiments of the present invention provide certain advantagesand overcome certain drawbacks of prior prostheses. Embodiments of theinvention may not share the same advantages, and those that do may notshare them under all circumstances. This being said, the presentinvention provides numerous advantages including the added advantages ofease of implantation, promotion of desired tissue or muscle ingrowthwithout involving surrounding tissue or organs, and reduction of tensionat the defect side.

Further features and advantages of the present invention, as well as thestructure of various embodiments, are described in detail below withreference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the invention will now be described, by way ofexample, with reference to the accompanying drawings, in which:

FIG. 1 is a top perspective view of an implantable prosthesis inaccordance with one illustrative embodiment of the present invention;

FIG. 2 is a top plan view of an implantable prosthesis in accordancewith another illustrative embodiment of the present invention;

FIG. 3 is a bottom plan view of the prosthesis of FIG. 2;

FIG. 4 is a cross-sectional view of a portion of the prosthesis takenalong section line 4-4 of FIG. 2;

FIG. 5 is an exploded top perspective view of the prosthesis of FIG. 2;

FIG. 6 is a top plan view of a layer of repair fabric for fabricatingthe tethers of the prosthesis of FIG. 2;

FIG. 7 is a top perspective view of the prosthesis of FIG. 2, with theaccess opening exposed to the pocket;

FIG. 8 is a cross-sectional view, similar to that of FIG. 4, inaccordance with a further illustrative embodiment of the presentinvention;

FIG. 9 is a top perspective view of the implantable prosthesis of FIG. 2used in conjunction with an onlay prosthesis in accordance with anotherillustrative embodiment of the present invention;

FIGS. 10-13 are schematic views illustrating repair of a trocar tractusing the prosthesis of FIG. 2 in accordance with another illustrativeembodiment of the invention; and

FIG. 14-16 are schematic views illustrating an umbilical hernia repairusing the prosthesis of FIG. 2 in accordance with a further illustrativeembodiment of the invention.

DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

The invention is directed to an implantable prosthesis for repairing oraugmenting anatomical defects, and is particularly suitable for therepair of openings in, and weaknesses of soft tissue and muscle walls orother anatomical regions. For ease of understanding, and withoutlimiting the scope of the invention, the prosthesis to which this patentis addressed is described below particularly in connection with theprophylactic repair of a trocar wound created during laparoscopicsurgery and with the repair of an umbilical hernia. It should beunderstood, however, that the prosthesis is not so limited and may beemployed in other anatomical procedures, as would be apparent to one ofskill in the art. For example, the prosthesis may be used for the repairor augmentation of a tissue or muscle wall hernia, such as an incisionalhernia, an inguinal hernia, a ventral hernia, a femoral hernia, andother tissue or muscle wall openings, as well as other puncture woundsor defects in addition to those formed by, and then left on removal of,a trocar and/or cannula.

The invention is more particularly directed to a repair device thatincludes a patch or plug having a body portion that is larger than atleast a portion of the opening or weakness so that placement of the bodyportion against the defect will cover or extend across that portion ofthe opening or weakness. The repair device further includes at least onetether that extends from the patch or plug and may be manipulated by asurgeon to position the patch or plug relative to the repair site and/orto secure the patch or plug relative to the opening or weakness in thetissue or muscle wall. The tether may be configured to extend throughthe defect and outside a patient's body to allow a surgeon to positionand/or manipulate the patch from a location outside the body. A portionof the tether may be attached directly to anatomy surrounding the edgesof the defect opening or to other neighboring tissue, muscle, skin orother anatomy, using a suture, staple, tack or other attachment devicewhether separate from or integrally formed with the tether, so as toanchor the patch in place. Any excess tether may then be removed.

An indicator may be arranged on the tether to aid a surgeon indetermining when the patch or plug has been inserted a sufficient depthor distance within a patient. The indicator may be located a desireddistance from the patch or plug such that its location relative to areference location provides an indication as to the position of thepatch or plug within the patient without direct visualization of thepatch or plug.

The tether may be configured as a strap having a cross-section with awidth that is greater than its thickness. The strap configurationpresents a relatively large surface area for the tether that may enhancethe amount of tissue integration to the tether, if desired. The strapconfiguration may also, or alternatively, act to distribute appliedforces acting on the tether across a relatively large area of the patchor plug as compared to a small area of the patch or plug as could occurif the tether was in the form of a length of suture material. The widthof the tether may extend across a portion or approximate the width ofthe body portion of the patch or plug. However, it should be appreciatedthat the invention is not limited in this respect, and the tether mayhave any suitable width, and its width may vary along the length of thetether.

The tether may be joined to the patch or plug at one or more junctionsso that forces acting through the tether may be applied to the patch orplug at those junctions. Multiple tethers may be joined to the patch orplug to enhance the positioning and anchoring of the patch or plug.

The tether may be configured from an elongated strip of a biologicallycompatible, implantable material, such as a knit fabric, or may be solidor substantially non-porous. The tether may be formed of a fabric thateither enhances tissue integration, inhibits adhesions with tissue, oris a combination of both, as desired. The material of the tether may bepermanent or absorbable. The patch or plug, similarly, may be formed ofa tissue infiltratable material such as a knit fabric, or may becomposed of a solid or substantially non-porous material. The tetherand/or the patch or plug may be formed of one or more layers of the sameor dissimilar material. The tether and the patch or plug may be formedwith portions that are tissue infiltratable and other portions that arenon-tissue infiltratable, providing selected areas of the repair devicewith different tissue ingrowth and adhesion resistant properties.

The repair device may be placed at the defect site using an opensurgical procedure, by laparoscopically passing the patch or plugthrough a cannula that extends along a puncture tract leading to thedefect, such as may be formed naturally or by a trocar, or through ahybrid procedure where an incision is formed through the skin and then atract is created in the underlying tissue and/or muscle leading to thedefect site along which the repair device is transported. The patch orplug may be flexible, allowing reduction of the repair device, such asby folding, rolling or otherwise collapsing the patch or plug, into aslender configuration suitable for delivery along the puncture tract, ora cannula extending through the puncture tract, to the defect site. Uponexiting the puncture tract or cannula, the patch or plug mayautomatically unfurl or may be unfolded, unrolled or otherwise deployedby the surgeon to an unfurled or expanded configuration suitable torepair the weakness or opening.

A support member may be arranged in or on the patch or plug to helpdeploy the patch or plug at the surgical site and/or help inhibitcollapse or buckling of the patch or plug. The support member may beconfigured as a complete or partial loop or a ring, criss-cross,x-shape, or any other suitable arrangement that helps to maintain adesired shape, and/or position, of the patch or plug despite tensionforces that may be applied on the repair device through the tether. Thesupport member may be rollable, foldable or otherwise collapsible, whenthe patch or plug is reduced in size for puncture tract or cannuladelivery, and may spring back, either automatically or upon theinfluence of a force (e.g., body heat where the support is formed of ashape memory material, such as NITINOL) to its expanded shape ondeployment at the repair site, influencing the patch or plug to assumeits unfurled or expanded configuration.

The patch or plug may be configured with a pocket or cavity tofacilitate the deployment and/or positioning of the patch or plug overthe opening or weakness. An access opening may be provided to allowaccess to the interior of the pocket. In this manner, the surgeon mayplace one or more fingers or an instrument through the access openingand into the pocket to ensure proper deployment and placement of thepatch or plug.

FIG. 1 illustrates one embodiment of a prosthesis 21 for repairing oraugmenting soft tissue and muscle wall defects, such as an umbilicalhernia or a trocar wound created in the abdominal wall of a patientduring a laparoscopic surgery.

The prosthesis 21 includes a body portion 22 of implantable,biologically compatible material that is configured to cover at least aportion of the defect. As shown, the body portion includes a patch thatmay be used as an underlay or an overlay. The patch may be configuredwith any desired strength, flexibility, tissue integration, adhesionresistance and/or other characteristics suitable for the repair as wouldbe apparent to one of skill. Although the body portion of the prosthesisis described in connection with a patch-type embodiment, the bodyportion may include a plug, a combination plug and patch, and othersuitable arrangements for mending the defect.

The prosthesis also includes a tether 24 extending from the patch 22 tofacilitate positioning and/or anchoring of the patch within a patient'sbody. As shown, the tether extends from a surface 34 of the patch thatis to face the defect 28 when the patch 22 is implanted in the patient'sbody. In this manner, the tether may be routed through the defect andmanipulated to position the patch over the defect. It should beappreciated that the tether may extend from any suitable portion of thepatch. Additionally, two or more tethers may be provided on the patch.

Since many tissue and muscle wall defects are relatively small and/orspace may be limited at the defect site, access to the patch eitherdirectly or using tools may be difficult for manipulating and/orpositioning it over the defect. Consequently, the tether 24 may beconfigured to extend through the anatomical defect to a location that isreadily accessible to the surgeon either within or outside the patient'sbody. In this manner, the surgeon may grasp and manipulate the proximalend 40 of the tether to position the patch within the body and againstthe defect. For example, after the patch is deployed at the defect site,the surgeon may pull on the tether to draw the patch into position overthe defect.

In certain procedures, including laparoscopic and open repairprocedures, the surgeon may desire to manipulate the patch 22 fromoutside the patient's body. In this regard, the elongated tether 22 maybe configured with a length that is sufficient to extend from theimplanted patch, through the defect and to a region that is accessiblefrom outside of the body of the patient. Preferably, the tether is sizedso that it protrudes outside the patient's body when the prosthesis isimplanted at the defect site to provide ready access to the tether bythe surgeon.

The length of the tether may be dictated by the location of the defectand/or the repair procedure. For example, a short tether may besufficient for repairing an umbilical hernia using open surgery, while alonger tether may be desired for a laparoscopic procedure in which thetether extends through a cannula. In one illustrative embodiment, thetether 24 may be configured with a length that ranges from approximately2.5 inches to approximately 20 inches. In one embodiment for repairingan umbilical hernia, the length of the tether is at least 2.5 inches,preferably at least 4 inches, more preferably at least 7 inches, andeven more preferably approximately 9 inches. In another embodiment forrepairing a defect using a laparoscopic procedure, the length of thetether is at least 10 inches, preferably at least 12 inches, morepreferably at least 14 inches, and even more preferably approximately 15inches for use with a cannula having a length of 6-6.5 inches. It is tobe appreciated that the disclosed tether lengths are exemplary and thatany suitable tether length may be employed for a particular repair.

In some procedures, it may be difficult for a surgeon to determine whenthe patch 22 has been inserted a required distance into the body to bepositioned at the repair site. In one illustrative embodiment, thetether 24 may include an indicator 60 disposed a predetermined distancefrom the patch. The appearance or disappearance of the indicator 60proximate the edge of the wound or the proximal end of a cannulaacknowledges that the patch 22 has been inserted a desired depth withinthe body cavity of the patient without direct visualization of thepatch, such as with a camera. For example, when the indicator 60 islocated proximate the proximal end of the cannula during laparoscopicinsertion of the patch, the indicator may reveal that the patch haspassed through the cannula and is deployed at the defect site. As arepresentative example, for a cannula having a length of approximately6-6.5 inches, the indicator may be located approximately 7.5-8.5 inchesfrom the patch. However, it should be appreciated that the invention isnot limited in this respect and that the prosthesis 20 need not employan indicator 60.

In one illustrative embodiment, the indicator 60 includes a series ofstitches formed with a thread having a contrasting color as compared tothe material of the tether. For example, the thread of the indicator maybe colored blue and the tether may be colored white. It is to beappreciated that other suitable indicators formed in other suitablemanners may be employed. For example, contrasting ink or dyes may beapplied to the tether, or the material of the tether may be treated tochange its appearance, texture, or shape, such as with a heat seal orindentation, to indicate the implantation depth of the patch. One ormore indicators 60 may be disposed on the tether at multiple locationsto indicate various desired or optional implantation locations of thepatch. For example, two or more indicators may be located on the tetherfor use with cannulas of differing lengths. The indicator 60 may alsonumerically indicate the depth of the implanted patch with a measuredand/or numbered indicator or ruler disposed on the tether. The indicatormay be preformed on the tether, or alternatively, may be formed on thetether by the surgeon at the desired implantation depth of the patch fora particular procedure.

As illustrated, the tether 24 has a strap-like configuration having across section with a width that is greater than its thickness. The strapconfiguration may distribute forces over a larger region of the patch ascompared to a suture-like tether. The strap may also present arelatively large surface area that may facilitate the repair, such as byenhancing tissue integration to the tether, if desired. Although thetether 24 is shown as having a constant width along its length, theinvention is not limited in this respect, and other strap configurationsmay be suitable. For example, the width of the strap may vary along thelength such that the strap is wider at its distal end and narrower atits proximal end. It is to be appreciated, however, that the tether isnot limited to a strap configuration as the prosthesis may employ anysuitable tether configuration apparent to one of skill.

The tether may be joined to the patch 22 using any suitable fastener orattachment arrangement. In the illustrative embodiment, the tether 24includes a base or foot that is stitched to the patch 22 along a stitchline 23. It is to be appreciated that other suitable attachment methodsmay be employed including, but not limited to, bonding, adhesives andother attachment methods apparent to one of skill in the art.Alternatively, the tether may be integrally formed with the patch, suchas by forming the tether and a portion of the patch from the same pieceof material.

The strap configuration may also reduce potential tearing of the tissueand muscle at the edge of the defect 28 by the tether 24 during andafter the repair procedure, particularly when compared to a suture-liketether. In this regard, the large surface area of the tether may resisttearing of the tissue and muscle proximate the defect when the tether ispulled during the procedure. In addition, the large width of the tethermay resist tearing through the tissue and muscle proximate the defectduring the healing process.

The tether is preferably flexible along its length from its distal end36 to its proximal end 40 to facilitate repair of a defect. Tofacilitate repair of a defect, the tether may be formed of a repairfabric that permits or is otherwise susceptible to tissue or muscleintegration. In one embodiment, the tether may include a plurality ofinterstices or openings which allow sufficient tissue or muscle wallingrowth to secure each tether to host tissue or muscle afterimplantation. However, the invention is not limited in this respect andthe tether may be formed of a material or otherwise configured toenhance tissue integration, inhibit adhesion, or a combination of both,as desired.

The patch may be anchored over to repair the tissue or muscle walldefect by attaching the tether 24 to or proximate the edge of the tissueor muscle defect. The tether may be attached to tissue, skin, and/ormuscle using any suitable attachment methods apparent to one of skill inthe art, such as sutures, tacks, and/or staples. In this manner, thedefect may be repaired in a tension free manner since it is notnecessary to reapproximate the tissue at the defect and/or to attach thepatch directly to tissue or muscle in the region of the defect.

The patch 22 may be configured to have any suitable shape or size thatis conducive to facilitating the correction or repair of a particulardefect. In the embodiment shown in FIG. 1, the patch 22 has a relativelyflat configuration. However, the patch need not be flat, and convex,concave, convex/concave, and more complex three-dimensional shapes alsoare contemplated, as noted above. The patch may be pliable to facilitatemanipulation and/or reduction of the patch during delivery to the defectand/or to conform the patch to the anatomical site of interest. Asillustrated, the patch has a generally circular shape. Examples of othershapes include, but are not limited to, oval, square, rectangular, andirregular configurations. The patch 22 may be sized to cover part or,preferably, all of the defect. In one embodiment, the patch 22 is sizedto extend slightly beyond the edge margins of the tissue or muscle walldefect. It should be understood, however, that any suitable size andshape may be employed for the patch.

The patch 22 may include one or more layers of repair fabric that maypromote tissue ingrowth to the patch, inhibit adhesions to the patch, ora combination of both. In one illustrative embodiment, the patchincludes an ingrowth layer 64 having a plurality of interstices oropenings which allow sufficient tissue or muscle ingrowth to integratethe prosthesis with the host tissue or muscle after implantation.Preferably, the ingrowth layer is formed of the same tissueinfiltratable material used for the tether. However, the invention isnot limited in this respect, as the ingrowth layer may be formed of anysuitable biologically compatible material apparent to one of skill.

To inhibit collapse of the patch 22 into the defect 28 when force isapplied to the tether, and/or to help deploy the patch into a planarconfiguration, it may be desirable to employ a patch that issufficiently rigid so that it can be easily and effectively manipulatedand positioned in the desired area, yet sufficiently flexible so thatthe patch is adequately tolerated by both the physician implanting thepatch and the patient receiving the patch. In one illustrativeembodiment as shown in FIG. 1, to balance the stiffness and flexibilitycharacteristics, the prosthesis 21 includes a resilient support member98 to reinforce portions of the patch 22 and to urge the patch to aplanar configuration. The support member 98 may be coupled to the patch22 in any suitable manner, as the present invention is not limited inthis respect. Suitable attachment methods include, but are not limitedto, stitching, bonding, adhesive, and integral formation with the repairfabric of the patch, as will be discussed further below.

The resilient support member 98 contributes to the stability of thepatch 22, allowing it to deploy into and remain in a desired shape. Forexample, the support member may aid in returning the patch to asubstantially unfurled or expanded configuration after the folded up orotherwise reduced implant has been delivered through the cannula. Thisstability facilitates deployment and placement of the patch by making iteasy to handle. Also, this stability minimizes the tendency of the patchto sag, fold, bend, collapse, or otherwise be dislocated. Difficulty inhandling, dislocation or bending could require additional operativeprocedures and/or additional anchoring during implantation.

As indicated above, a prosthesis for repairing or augmenting soft tissueand muscle wall defects, such as an umbilical hernia or a trocar woundcreated in the abdominal wall of a patient during a laparoscopicsurgery, may include a body portion of any suitable configuration andone or more tethers extending from the body portion.

In another illustrative embodiment shown in FIGS. 2-7, the prosthesis 20includes a patch 22 for covering at least a portion of the defect, and apair of tethers 24, 26 extending from the patch to facilitatepositioning and/or anchoring of the patch at the defect site. As shown,the tethers extend from a surface 34 of the patch that is to face thedefect 28 when the patch 22 is implanted in the patient's body so thatthe tethers may be routed through the defect. Each tether is configuredwith a length that is sufficient to extend through the defect to aregion that is accessible from outside the body, as described above.Additionally, each tether has a strap-like configuration similar to theembodiment of FIG. 1. It is to be understood, however, that the tethersmay be configured with any suitable size and shape apparent to one ofskill.

As illustrated in the embodiment of FIGS. 2-7, the tethers 24, 26 extendfrom the patch at spaced apart junctions 44, 46 between the tethers andthe patch 22. In this manner, the spaced junctions transfer forces fromthe tethers to different portions of the patch, rather than applying theforces in a more concentrated region. This arrangement may enhance forcedistribution across the patch so as to reduce the potential forcollapsing the patch into the defect and pulling the patch through thedefect. The spaced junctions between the tethers and the patch may alsofacilitate positioning and manipulation of the patch. In this regard,tension may be applied to one or the other of the tethers to guide ordirect the patch, similar to reins. However, it should be appreciatedthat the invention is not limited in this respect, and that the tethersmay be joined or attached to the patch in other suitable locations.

To secure the patch 22 to repair the tissue or muscle wall defectwithout reapproximating the tissue or muscle surrounding the defect, thetethers 24, 26 may be attached to opposite edges of the tissue or muscledefect. In this manner, forces applied to the patch 22 by the tethersare relatively balanced to the body of the patch, and thus, facilitatemaintenance of the patch in its desired implantation position. It is tobe appreciated that other suitable attachment arrangements of thetethers may be used as would be apparent to one of skill. For example,the tethers may each be attached to the same side of the defect. Asdescribed above, the tethers may be attached to the tissue, skin, and/ormuscle using suitable attachments known in the art, such as sutures 54,tacks, and/or staples. In this manner, the defect may be repaired in atension free manner since it is not necessary to reapproximate thetissue at the defect, and the patch is anchored over the defect with thetethers secured to the opposing edges of the defect.

In certain repairs, it may be desirable to vary forces at differentregions of the patch. In one embodiment, the tethers 24, 26 may bejoined to the patch 22 at junctures 44, 46 which are not symmetric aboutthe center of the patch. In another embodiment, one strap 24 may belonger than the other strap 26 after the straps are attached to securethe patch 22. In this manner, extending the tethers from differentlocations of the prosthesis and/or employing straps of differing lengthsor sizes may act to spread the forces to the patch in a predeterminedmanner.

As illustrated, the prosthesis may include an indicator 60, as describedabove, as an aid for a surgeon in determining when the patch 22 has beeninserted a sufficient distance within the patient. The indicator 60 maybe provided on either one or both tethers 24, 26. In the illustrativeembodiment of FIGS. 2-7, the indicator includes a thread that attachesthe tethers to each other.

In certain procedures, such as a laparoscopic procedure, the prosthesis20 may be used to repair a fairly small trocar wound that itself may betoo narrow for delivery of the patch 22. One approach is to deliver thepatch 22 and the attached tethers 24, 26 to the wound site 28 through aseparate cannula or entry wound that is large enough to accommodatetransport of the patch. In this manner, the patch may be deployed at ornear the slender trocar wound and at least a portion of the tethers areaccessible for the surgeon to retrieve and extract the tethers throughthe defect 28. The tethers may then be pulled, pushed, or otherwisemanipulated. In this manner, the indicator of a contrasting color mayhelp the surgeon locate the tethers inside the body cavity to ease theextraction of the tethers through the defect to be repaired.

In the illustrative embodiment of FIGS. 2-7, the prosthesis 20 includesa patch 22 which is relatively flat and circular. However, the patchneed not be flat and/or circular, and three dimensional and other shapesmay be suitable, as discussed above.

The patch may include an ingrowth layer 64 of tissue infiltratablematerial to enhance the repair of the defect. The ingrowth layerincludes at least one layer of repair fabric that permits or isotherwise susceptible to tissue or muscle ingrowth. In the embodiment ofFIGS. 2-7, the ingrowth layer 64 includes first and second layers 66,68. Each layer 66, 68 is formed of a biologically compatible, flexiblerepair material that includes a plurality of interstices or openingswhich allow sufficient tissue or muscle ingrowth to integrate theprosthesis with host tissue or muscle after implantation. Multiplelayers of tissue infiltratable fabric may enhance the strength of thepatch and/or the amount of tissue ingrowth to the patch. Preferably, thefirst and second layers are formed of the same tissue infiltratablematerial as that of the tethers. However, the invention is not limitedin this respect, and either one or both layers may be formed of anybiologically compatible material, suitable for repairing a tissue ormuscle wall defect as would be apparent to one of skill.

In one embodiment, the tethers 24, 26 and ingrowth layers 64, 66, 68 ofthe prostheses 20, 21 are formed from a sheet of knitted polypropylenemonofilament mesh fabric such as BARD MESH available from C. R. Bard,Inc. When implanted, the polypropylene mesh promotes rapid tissue ormuscle ingrowth into and around the mesh structure. Alternatively, othersurgical materials which are suitable for tissue or muscle reinforcementand defect correction may be utilized including SOFT TISSUE PATCH(microporous ePTFE—available from W. L. Gore & Associates, Inc.);SURGIPRO (available from US Surgical, Inc.); TRELEX (available fromMeadox Medical); PROLENE and MERSILENE (available from Ethicon, Inc.);and other mesh materials (e.g., available from Atrium MedicalCorporation). Absorbable materials, including polyglactin(VICRYL—available from Ethicon, Inc.) and polyglycolic acid(DEXON—available from US Surgical, Inc.), may be suitable forapplications involving temporary correction of tissue or muscle defects.Collagen materials such as COOK SURGISIS, available from CookBiomedical, Inc. may also be used. It also is contemplated that the meshfabric may be formed from multifilament yarns and that any suitablemethod, such as knitting, weaving, braiding, molding and the like, maybe employed to form the tether mesh material. Alternatively, the tethermay be formed of a monofilament of any of the above materials or asuture material, which may be absorbable or non-absorbable. It ispreferable that the material of the tether have a tensile strength ofapproximately 3 lb. force or more.

To ensure adequate tissue ingrowth to the patch occurs, the layers 66,68 may be attached or joined in a way that would permit tissue to growinto the pores of the first and second layers and provide a strong bondbetween the surrounding muscle or tissue in the first and second layers.In one embodiment, the first and second layers are connected withstitches 70, 72 proximate the periphery 74, 76 of each layer.

It should be appreciated that the invention is not limited to anyparticular attachment method, as the first and second layers 66, 68 maybe attached using other suitable techniques. For example, the layers maybe bonded together by melting the layers at specific locations or in aspecific pattern; sonic, induction, vibration, or infrared/laser weldingthe layers; or using a suitable bonding agent. The point or points ofattachment may comprise any suitable pattern, such as a spiral pattern,a serpentine pattern, or a grid-like pattern of dots or beads, thatmaintains a sufficient quantity of open or non-impregnated intersticesfor tissue or muscle infiltration.

To aid in deploying and/or positioning the patch during implantation,the patch 22 may include a pocket 78. In this manner, a physician mayuse the pocket 78 to deploy or position the patch in the desired area orimplantation location. In the embodiment shown in FIGS. 2-7, the firstand second layers 66, 68 are attached in a manner to form a pocket 78therebetween. However, it should be appreciated that the invention isnot limited in this respect and that a pocket need not be employed orthat other suitable pockets formed in other suitable manners may beemployed. For example, a pocket may be formed from an additional layerof material or portion thereof attached to the first layer 66 and/or thesecond layer 68.

To gain access to the interior of the pocket 78, the patch 22 includesan access opening 80. In one embodiment, the opening 80 includes atransverse cut or slit formed in the second layer 68 which may follow adiameter of the patch. It should be recognized that the access openingmay be oriented in any position and located across any portion of thepatch as may be suitable for the repair procedure.

To position and/or deploy the patch, the surgeon may insert one or morefingers (or suitable surgical instrument) through the access opening andinto the pocket to manipulate the patch into place. In one embodiment,the pocket 78 is sized to accept at least one finger of the surgeon'shand or a tool for positioning the implant, although other suitablysized pockets may be employed as the present invention is not limited inthis respect. Further, the pocket may be formed as multiple pockets sothat one or more fingers or instruments may be inserted into individualsections. In the embodiment shown in FIGS. 2-7, the pocket 78 includes afirst side pocket 82 and a second side pocket 84 on opposing sides 86,88 of the opening. However, it should be appreciated that the inventionis not limited in this respect and that only a single central or off-setpocket may be employed.

As illustrated, the tethers 24, 26 are attached to the second layer offabric 68, which is itself attached to the first layer of fabric 66 atits periphery 74, 76. As force is applied to the tethers, the secondlayer of fabric will tend to billow from the first layer of fabric. Theforces on the tethers are transmitted through the second layer of fabricand to the first layer of fabric at the peripheral attachment of thefirst and second layers of repair material. In this manner, theattachment of the tethers to the second layer may act to inhibitcollapse of the prosthesis by spreading forces to the periphery of thepatch.

The tethers 24, 26 may be attached to the second layer of fabric 26 onopposing sides 86, 88 of the access opening 80, as shown in FIGS. 2-7.As force is applied to the tethers, the billowing second layer 68 mayopen and expand the access opening 80 to the pocket 78. The gapingaccess opening spreads or spaces apart the junctions 44, 46 of thetethers 24, 26 and the patch. In this manner, the temporary spacing ofthe junctions 44, 46 spreads the forces on the tethers away from thecenter and towards the periphery of the patch.

To further enlarge the access opening 80 during the repair procedure,the surgeon may pull the tethers 24, 26 away from each other. In thismanner, the access opening can be drawn open, allowing less restrictedaccess to the pocket 78 to position or manipulate the patch. The exposedaccess opening between the tethers and through the defect may alsofacilitate access to the broad surface 30, 32 of the tethers 24, 26 whenattaching the tethers to the edges of the defect. Additionally oralternatively, sutures, staples, or tacks (not shown) may be placedthrough the patch, if desired, into surrounding tissue and/or muscle tosecure the prosthesis.

To facilitate the fabrication of the prosthesis, the tethers may beintegrally formed with the second fabric layer. In one illustrativeembodiment shown in FIG. 6, an elongated piece of repair fabric includesa pair of layer portions 68A, 68B disposed at opposite ends of anelongated strap. The layer portions may be configured so as to form adesired shape of the second fabric layer. As shown, each layer portion68A, 68B may be configured with a semi-circular shape to form a circularsecond layer when combined. The strap may be folded in half along a foldline 96 to form the first and second tethers 24, 26 between the foldline 96 and the layer portions. Each half of the second layer of fabricmay be folded out to form the generally planar second layer 68 at thedistal end of the tethers. In this manner, the access opening 80 isformed between the two tethers and each half of the second layer offabric.

As illustrated, the proximal ends 40, 42 of the tethers are joined toform a loop or handle that may be grasped and pulled by the surgeon. Ifdesired, the proximal ends of the tethers may be separated before,during, or after implantation of the prosthesis. It should also beappreciated that the tethers 24, 26 may be separately attached to thepatch in other suitable locations. Additionally, the tethers may bejoined to any one or all layers of the patch.

To inhibit collapse of the patch 22 into the defect 28 when force isapplied to the tethers 24, 26, and/or to help deploy the patch into aplanar configuration, a resilient support member may be disposed on thepatch. In one embodiment, the resilient support member 98 includes asubstantially continuous loop or ring positioned adjacent the outermargin 100 of the patch 22. In the embodiment shown in FIGS. 2-7, thesupport member 98 is spaced inwardly from the outer peripheral edges 74,76 of the layers of fabric 66, 68. However, it should be appreciatedthat the present invention is not limited in this respect, as thesupport member may be disposed at the peripheral edge and/or at discretelocations throughout the body of the patch.

In the embodiment shown, the support member 98 includes a monofilamentof a desired thickness and cross-sectional shape to provide a desireddegree of resilience or rigidity. It should be appreciated that thesupport member may have any cross-sectional shape, such as circular,square, rectangular, triangular, elliptical, etc. The support member maybe configured on the patch in any pattern, such as a spiral pattern, asquare pattern, an elliptical pattern, a circular pattern, criss-crosspattern or the like.

The stiffness or rigidity of the support member may be varied dependingon the size of the patch. For example, the cross-sectional diameterand/or the spring constant of the material of the monofilment thread maybe varied in a manner to provide a desired stiffness. In one embodiment,for a patch 22 having a diameter of approximately 1.75 inches, thesupport member 98 is formed from a segment of 0.03 inch polyethyleneterephthalate (PET) monofilament thread having a length of approximately3.375 inches. In this manner, the monofilament thread may be formed intoa loop having a diameter of approximately 1.1 inches. In anotherembodiment for a patch having a diameter of approximately 2.5 inches,the support member may be formed from a segment of 0.030 inch PETmonofilament thread having a length of 5.94 inches. In this manner, themonofilament thread may be formed into a loop having a diameter ofapproximately 1.81 inches. However, it should be appreciated that theinvention is not limited in this respect and that the support member maybe made of any suitable material including nylon, polypropylene, andpolyester and having any suitable diameter or cross-section.

The support member 98 may be disposed on the patch 22 in any suitablemanner as the present invention is not limited in this respect. In oneembodiment, as shown in FIGS. 2-7, the resilient support member 98 issandwiched between the first and second layers of repair fabric 66, 68and may or may not be physically attached thereto. The support membermay be tightly or loosely held within a channel 102 between the firstand second layers 66, 68 and formed by a pair of seams joining the firstand second layers. In the illustrative embodiment, the channel 102 isformed by a pair of seams 70, 72 that follow the contour of theperiphery 74, 76 of the layers. The seams may be formed by a series ofstitches extending along the outside and inside edge of the resilientsupport member 98 to keep it from moving with respect to the first andsecond layers. Because of the rigidity of the resilient support member,one seam extending along one side of the support member may besufficient.

Alternatively, rather than being sandwiched between the first and secondlayers 66, 68, the support member 98 may overlie or underlie theingrowth layer 64 and may be attached, regardless of location, withstitches or a bonding agent, or fused with ultrasonic, induction,vibration, infrared/laser welding and the like. Alternatively, thesupport member may be woven through at least one of the layers orintegrally formed with one or both layers as the layer itself is beingmade.

Although the support member 98 is described as being formed of amonofilament, other suitable constructions may be employed. For example,the support member may be molded elements that are subsequently attachedto the patch or molded onto the patch. As another example, the supportmember may be formed from the ingrowth layer 64. In this respect, thesupport member may be formed by melting a portion of the ingrowth layerin any desired shape. The support member may be formed by applying heatto the ingrowth layer at a temperature range of approximately 320° F. to400° F. for a period of approximately 3-5 seconds. In another example,the support member may be formed by multiple stitches passing throughone or both layers, such as, for example, an embroidered section.Alternatively, the support member may be formed by altering the weavepattern in a zone of desired reinforcement. In this manner, the area ofthe ingrowth layer where tissue ingrowth is desired may be formed with arelatively loose open weave, whereas the area or zone of reinforcementmay be formed with a relatively tight weave, to provide the desiredrigidity. Other suitable methods or mechanisms to form the supportmembers may be employed, as the present invention is not limited in thisrespect. Although some embodiments described above include supportmembers, the present invention is also not limited in this respect.

In certain procedures, such as in the repair of trocar wounds in thechest or abdominal wall or groin region, it may be desired to limit orprevent contact between the ingrowth layer 64 and certain tissue, muscleor organs. Such contact could potentially lead to undesirablepostoperative adhesions between the ingrowth layer and the surroundingtissue, muscle or organ and/or erosion of the ingrowth layer into theneighboring anatomy or other injury. To minimize or eliminate theincidence of postoperative adhesions to selected portions of the patch22, or other trauma, the prosthesis 20 may include an adhesion resistantbarrier overlying at least a portion, and preferably all, of one side ofthe ingrowth layer.

In one illustrative embodiment as shown in FIGS. 2-7, a barrier layer104 is attached to the side 106 of the patch 22 adjacent the first layer66 that is to face away from the defect 28. The patch 22 is to bepositioned in the patient such that the barrier layer 104 faces theregion of potential undesired adhesion, such as the abdominal viscera(e.g., intestines) or the thoracic viscera (e.g., heart or lungs). Thebarrier layer is formed of a material and/or with a structure that doesnot substantially stimulate and, in certain embodiments, may resisttissue, muscle or organ ingrowth and adhesion formation when implanted,thereby reducing the incidence of undesired postoperative adhesionsbetween the ingrowth layer 64 and adjacent tissue, muscle or organs.

In one embodiment, the barrier layer 104 is formed from a sheet ofexpanded polytetrafluoroethylene (ePTFE) having fibril lengths—alsoreferred to as pore size or internodal distance—that will not permitsignificant tissue ingrowth. In one embodiment, the fibril lengths ofthe ePTFE are less than 5 microns. In another embodiment, the fibrillengths of the ePTFE are less than 1 micron and in still anotherembodiment, the fibril lengths are less than 0.5 microns. Examples ofother suitable materials for forming the barrier layer 104 includeFLUORO-TEX Pericardial and Peritoneum Surgical Membrane and FLUORO-TEXDura Substitute available from C. R. Bard and PRECLUDE PericardialMembrane, PRECLUDE Peritoneal Membrane and PRECLUDE Dura Substitutemembrane available from W. L. Gore & Associates, Inc. A representativeand non-limiting sampling of other suitable micro to non-porousmaterials includes silicone elastomer, such as SILASTIC Rx Medical GradeSheeting (Platinum Cured) distributed by Dow Corning Corporation, andmicroporous polypropylene sheeting (available from Celgard, Inc.) andfilm. Autogenous, heterogenous and xenogeneic tissue also arecontemplated including, for example, pericardium and small intestinesubmucosa. Absorbable materials, such as SEPRAFILM available fromGenzyme Corporation and oxidized, regenerated cellulose (Intercede(TC7)) may be employed for some applications. It is to be appreciatedthat other suitable biocompatible adhesion resistant materials also maybe used.

To permit and facilitate tissue or muscle growth into the first layer ofrepair material 66, the barrier layer 104 is preferably attached to thefirst layer 66 in a way that would permit tissue to grow into the poresof the first layer and provide a strong bond between the surroundingmuscle or tissue and the first layer. In one embodiment, the barrierlayer is attached to the ingrowth layer with stitches. Although theattachment is shown to include concentric patterns of stitch lines, anysuitable pattern may be employed so as to minimize separation of theingrowth layer 64 and the barrier layer 104, to minimize the number ofstitching holes through the barrier layer and to facilitate themanufacturing process. It should also be appreciated that the barrierlayer may be attached using other suitable materials, techniques and/orpatterns. For example, the barrier layer may be bonded to the ingrowthlayer by heating the layers, by welding the layers, or using a suitablebonding agent. Any suitable pattern, such as a spiral pattern, aserpentine pattern, or a grid-like pattern of dots or beads may be usedprovided there is a sufficient quantity of open or non-impregnatedinterstices maintained in at least one layer for tissue and muscleinfiltration.

In one embodiment, as shown in FIGS. 2-7, the first and second layers ofrepair fabric 66, 68 are attached together and to the barrier layer atdiscrete attachment lines using stitches, which allow sufficient tissueinfiltration to the ingrowth layer, while providing a connection betweenthe first and second layers and the barrier layer. In addition, some orall of the stitches may be used to secure only the first and secondlayers of repair fabric. In the embodiment shown, the first or outerline of stitches 72 attach only the first and second layers of repairfabric 66, 68, whereas the second or inner line of stitches 74, formingthe channel 102 for the resilient support member 98, attach the firstand second layers of repair fabric 66, 68 with the barrier layer 104. Inthis manner, the number of holes created by stitches in the barrierlayer 104 are decreased to minimize the leakage of gases, such as thoseto insufflate the body cavity during a laparoscopic procedure.

To further minimize any undesired adhesions, the stitches 74 may beformed from a non-porous, adhesion resistant material. In oneembodiment, the stitches 74 are formed with a suitablepolytetrafluoroethylene (PTFE) monofilament. The PTFE stitches mayprovide a softer, more flexible prosthesis that is easier to manipulateas compared to a prosthesis using other stitch materials, such aspolypropylene monofilament. PTFE monofilament also facilitates themanufacturing process due to the low friction characteristics of thematerial. Nevertheless, it should be understood that any suitablematerial, such as polypropylene monofilament, may be employed for thestitches. For example, because some of the stitch lines 72 do not passthrough the barrier layer, or where no barrier layer is employed,materials other than an adhesion resistant material may be employed. Forease of manufacturing however, typically, all stitches 72, 74 are formedof the same material, although the invention is not limited in thisrespect.

The layers 66, 68, 104 may be stitched using a typical sewing stitchformed by a sewing machine using a bobbin and sewing thread. Preferably,the barrier layer 104 is positioned on the ingrowth layer 64 to face thesewing needle so that the locking position of each stitch (i.e. thebobbin) is formed on the ingrowth side 34 of the patch 22 rather than onthe barrier side 106 to reduce the incidence of localized adhesions withtissue, muscle or organs. The stitches 72, 74 may be formed using a #10ball-tipped needle to reduce the potential incidence of ingrowth throughthe stitch holes. The sheets of ingrowth material 66, 68, with orwithout the barrier layer 104, may be held by a frame during the sewingprocedure on a computer controlled table that has been programmed withthe desired stitch pattern.

While the barrier layer 104 preferably covers the entire surface of oneside 106 of the ingrowth layer 64, the barrier layer may be configuredto cover only selected portions of one side of the patch to enhanceingrowth from both sides in those portions free of the barrier layer.Similarly, the patch may be configured such that the barrier layercovers the entire surface on one side 106 of the patch and covers one ormore portions of the other side 34 of the patch.

In some instances, it may be desirable to isolate the outer peripheraledge 110 of the patch 22 from adjacent tissue, muscle or organs. In oneembodiment, a peripheral barrier 108 extends completely about the outerperipheral edge 110 of the patch to inhibit adhesions thereto. It is tobe understood, however, that the peripheral barrier may be configured tocover only those selected portions of the outer peripheral edge of theprosthesis where protection from the formation of postoperativeadhesions is desired.

The peripheral barrier 108 may be formed integrally with either theingrowth layer 64 or the barrier layer 104. Alternatively, theperipheral barrier may be formed by a separate component that isattached to or incorporated into the outer peripheral edge of theprosthesis. In one illustrative embodiment, the peripheral barrier isformed from a portion of the ingrowth layer. In particular, the ingrowthlayer may be altered so as to substantially eliminate the tissueinfiltratable interstices or openings along its outer margin, therebycreating a peripheral barrier.

In one embodiment, as shown in FIGS. 2-7, the peripheral edges 72, 74 ofthe layers of repair fabric 66, 68 are melted to seal the material andform an outer peripheral barrier 108. The barrier layer 104 may beconfigured, such as with submicronal sized pores, so that a portion ofthe melted material of repair layers become fused to the barrier layer.The peripheral edge 110 of the patch may be melted using any suitableprocess. In one embodiment, the peripheral edge may be melted by heatsealing the layers of repair fabric 66, 68. In the exemplary embodiment,the peripheral barrier 108 is formed by melting a ring of polypropylenemesh fabric 66, 68 to the ePTFE barrier layer 104 in a shape thatapproximates the desired configuration of the patch 22. This may beaccomplished by overlying oversized sheets of the mesh fabric and ePTFEmaterial in a fixture and heat sealing the layers using a heated dieconfigured with the desired shape of the prosthesis. The melted ring maybe formed by applying heat to the fabric at a temperature range ofapproximately 320° F. to 440° F. for a period of approximately 3 to 5seconds. The temperature chosen typically should be below the sinteringtemperature of the ePTFE barrier layer. Other sealing techniques may beused, such as ultrasonic, induction, vibration, infrared/laser weldingand the like, as the present invention is not limited in this respect.Once fused, the ingrowth layer is stitched to the barrier layer, asdescribed above, and subsequently die cut flush along a portion of thering to complete the patch with a peripheral barrier.

In an exemplary embodiment for the prosthesis of FIG. 2-7, the first andsecond layers 66, 68 and the two tethers 24, 26 are each formed from anapproximately 0.027 inch thick sheet of BARD MESH knitted frompolypropylene monofilament with a diameter of approximately 0.006inches. Each tether is integrally formed with the second layer of repairfabric from a single sheet of BARD MESH. The access opening 80 in thesecond layer and between the tethers extends across the diameter of thesecond layer and between the stitch lines of the second or inner stitchline 72. The surface barrier 104 is formed from an approximately 0.006to 0.008 inch thick sheet of ePTFE. The surface barrier and the firstand second layers are attached with approximately 3 mm to 4 mm longstitches formed of a 0.008 inch to 0.012 inch diameter PTFEmonofilament. The first or outer stitch line 70 attaches only the firstand second layers and is placed approximately 0.5 cm in from theperipheral edge of the layers of repair fabric. The second or innerstitch line 72 attaching the first and second layers to the surfacebarrier is placed approximately 1 cm in from the peripheral edge of thelayers and the surface barrier. The resilient support member 98 is acontinuous loop formed from an approximately 0.03-0.042 inch diameterPET monofilament. The resilient support member is held in the 0.5 cmchannel 102 formed between the first and second stitch lines 72, 74. Theouter 0.5 cm of the peripheral margin 100 of the first and second layersare heat sealed to the surface barrier to supplement attachment of thefirst layer, the second layer, and the surface barrier. Each tether isapproximately 0.62 inches wide and has a length of approximately 15inches. The patch location indicator 60 includes a stitch line formedfrom approximately 0.0068 inch diameter blue unannealed polypropylenemonofilament thread that is colored blue. The indicator stitch line islocated approximately 8 inches from the distal ends 36, 38 of thetethers, and attaches the two tethers to each other to form a loop.

In an illustrative embodiment shown in FIG. 8, the peripheral margins100 of the first layer 66, the second layer 68, and the surface barrier104 are heat melded to seal the outer periphery of the layers and formthe peripheral edge barrier 108. The channel 102 for the support member98 is formed between the heat seal 108 and a single line of stitches 74attaching the first and second layers to the surface barrier. In thismanner, the number of stitch holes in the patch are decreased.

In some repair procedures, it may be desired to employ a tetheredprosthesis in conjunction with one or more other prostheses. In oneillustrative embodiment shown in FIG. 9, the prosthesis of FIGS. 2-7 maybe employed in conjunction with an overlay prosthesis 116 for repairingan inguinal hernia. The overlay prosthesis 116 is sized and shaped tooverlay the defect such that the defect is sandwiched between thetethered prosthesis 20 and the overlay prosthesis 116. To repair thedefect and to attach the prosthesis 20 to the overlay prosthesis 116,the tethers 24, 26 of the prosthesis 20 may be routed through the defectand threaded through tether openings 118, 120 in the overlay patch 116.In this manner, the tethers are slidably attached to the onlay patch.However, the invention is not limited in this respect and the tethersmay be joined or attached to the onlay patch in any suitable manner,including sutures, melding, and bonding.

Tension may be applied to the tethers to draw the patch 22 against theunderside of the defect from a remote location. The onlay patch 116 mayalso be positioned on the top side of the defect by pulling the tethers24, 26 in opposing directions to slide the onlay patch down the tethersand more proximate to the defect below the onlay patch. The onlay patchmay be attached to tissue, muscle or other anatomy proximate the defectas would be apparent to one of skill in the art. The tethers may beattached directly to the onlay patch or to tissue, muscle, or otheranatomy proximate the defect, as desired by the surgeon. The excesstether may then be removed and disposed.

In the embodiment shown in FIG. 9, the tether openings 118, 120 areelongated cuts or slits formed in the fabric of the onlay patch 116. Theslits 118, 120 may extend generally parallel to the periphery of theonlay patch. However, it should be recognized that the tether openings118, 120 may be oriented in any manner in relation to the peripheryand/or body of the onlay patch, and may have any shape to accommodatethe tethers and/or anatomy proximate the defect.

One or more tether openings may be provided in the onlay patch toprovide various configurations for the attachment between the tethersand the onlay patch. In the illustrative embodiment, a first pair oftether openings 118, 120 are provided in the onlay patch 116 to repair adirect inguinal hernia, and a second pair of tether openings 122, 124are provided in the onlay patch to repair an indirect hernia. However,it should be appreciated that the invention is not limited in thisrespect, and that any number of tether openings may be placed in anysuitable configuration for repairing the tissue or muscle wall defect.

The onlay patch may also include one or more tether holes for securingthe tethers to the patch. As illustrated, a tether hole 126 is providedin the onlay patch 116 adjacent each of the tether holes 118, 120, 122,124. The tethers 24, 26 may be inserted into the onlay patch througheither set of tether holes 118, 120 or 122, 124. To facilitate anchoringthe tethers, the tethers may be woven through the onlay patch bythreading the tethers through adjacent tether holes 126.

The onlay patch may be formed of a biologically compatible, flexiblelayer of repair fabric suitable for reinforcing tissue or muscle walland closing anatomical defects. In one illustrative embodiment, theonlay patch is formed of a layer of tissue infiltratable repair fabric128 in a generally D shape, with a lateral edge 130 and a rounded medialedge 132. A keyhole opening 134 may be formed at the end of a slit 136that extends inwardly from the lateral edge 130 of the onlay patch tocreate a pair of tails 138, 140. The pair of tails may be separated toreceive a tube-like structure, such as the spermatic cord in an inguinalhernia repair. However, it should be recognized that the onlay patch maybe configured to have any suitable shape that is conducive tofacilitating repair of a particular defect.

To isolate portions of the fabric 128 from the adjacent tube-likestructure, portions of the fabric 128 may be covered with a surfacebarrier 142. In the illustrative embodiment, the surface barrier extendsinwardly from the medial edge of the fabric 128 to the keyhole opening134. To further protect the tube-like structure from the edges of thefabric at the keyhole opening, the onlay patch 116 may also include anedge barrier 144. The edge barrier 144 may be configured as a flap 146of the surface barrier which may then be wrapped around the tube-likestructure as it passes through the keyhole opening. One example of anonlay patch 116 is disclosed in U.S. Pat. No. 6,258,124 to Darois etal., assigned to C. R. Bard, Inc. However, the invention is not limitedin this respect and the prosthesis 20 may be used without an onlay patchor with an onlay patch having any suitable configuration.

It is to be understood that the above embodiments are exemplary and anysuitable patch and tether configuration may be implemented to repair atissue or muscle wall defect.

One embodiment of a repair procedure to implant the prosthesis to repaira trocar wound will now be described with reference to FIGS. 10-13. Thedefect 28 is identified by the placement of the cannula 58 during alaparoscopic procedure. However, it is to be appreciated that theinvention is not limited in this respect, and a cannula 58 need not beemployed to deliver the patch 22 and the opening of the defect need notbe located through the skin of the patient.

To deliver the prosthesis to the defect site, the patch is folded inhalf to form a taco-like configuration and then held in the jaws of agrasper 112. The distal end of the grasper 112 is then advanced throughand out of the cannula 58 and to the surgical site as shown in FIG. 10.

When the patch 22 is clear of the distal end side of the cannula 58, asindicated either by the location of the indicator 60 relative to thecannula, by the sensed change in feel of the grasper, or byvisualization with a laparoscopic camera, the jaws of the grasper 112are opened, releasing the folded patch 22. The resilient support member98, no longer confined by the graspers, expands deploying the patch 22into a substantially planar configuration as shown in FIG. 11. The freeproximal ends of the tethers 24, 26 are then pulled away from thecannula, drawing the patch 22 up against the distal end 56 of thecannula 58 as shown in FIG. 12.

While maintaining tension on the tethers, the cannula is slowly removedfrom the defect, seating the patch against the defect. The tethers arethen pulled away from each other, providing access to the pocket 78 inthe patch. The physician may probe with her finger about the pocket toensure proper deployment and placement of the patch over the defect. Thetethers 24, 26 may then be attached to the tissue and muscle adjacentthe defect as shown in FIG. 13. In the repair of a trocar wound in theabdominal cavity, the tethers may be attached with sutures 54 to thefascia or to the abdominal wall near the edge of the defect. Any excesstether length 114 may then be cut and discarded. The skin overlying thedefect may then be closed by suturing or other conventional approach.

One embodiment of an umbilical hernia repair will now be described withreference to FIGS. 14-16. Upon identifying the defect 28, a smallincision is made over the hernia. The hernia sac 160 may be dissectedout and divided, as shown in FIG. 14, with a cutting instrument, such asa scissors 164 or scalpel. The contents of the hernia sac may then bereduced, and the sac 160 ligated. A finger or peanut sponge may beinserted into the defect 28 to clear off the underside of the peritoneumproximate the incision over the defect. To deliver the prosthesis to thedefect site, the patch 22 is folded in half to form a taco-likeconfiguration and then held in the jaws of the grasper 112, as shown inFIG. 15. The defect may be retracted and the distal end of the grasper112 is then advanced through the defect and into the intra-abdominalspace and to the surgical site.

When the patch 22 is cleared of the defect opening, such as may beindicated by the location of the indicator relative to a referencepoint, the jaws of the grasper 112 are opened, releasing the foldedpatch 22. The resilient support member 98 of the patch, no longerconfined by the graspers, expands and deploys the patch 22 into asubstantially planar configuration. The free proximal ends of thetethers 24, 26 are then pulled away from the wound, drawing the patch 22against the abdominal wall, as shown in FIG. 16.

The physician may sweep circumferentially about the patch to make surethat the patch is lying flat and that there is nothing such as the bowelor omentum, caught between the patch and the abdominal wall. The tethersmay then be pulled away from each other, providing access to the pocket78 and the patch. The physician may probe with her finger about thepocket to ensure proper deployment and placement of the patch over thedefect. Additionally, while pulling up on the positioning tethers, thephysician may insert a finger or peanut sponge into the defect and inbetween the surface of the patch facing the defect and the peritoneum.

The tethers 24, 26 may then be attached to the tissue and muscle orother anatomy adjacent the defect, similarly as shown with reference toFIG. 13. In the repair of an umbilical hernia in the abdominal cavity,the tethers may be attached with sutures 54 to the fascia or to theabdominal wall near the edge of the defect. Any excess tether length 114may then be cut and discarded. Skin overlying the defect may then beclosed by suturing or other conventional approach.

It should be understood that the foregoing description of the inventionis intended merely to be illustrative thereof and that otherembodiments, modifications, and equivalents of the invention are withinthe scope of the invention recited in the claims appended hereto.Further, the prostheses described above include various features thatmay be employed singularly or in any suitable combination.

What is claimed:
 1. An implantable prosthesis for repairing an abdominalwall defect, the implantable prosthesis comprising: a multi-layer softtissue repair patch including a first mesh layer, a second mesh layerand an adhesion resistant barrier layer, the first mesh layer locatedbetween the second mesh layer and the barrier layer; and at least onetether extending from a side of the repair patch opposite the barrierlayer, the tether including a mesh portion integrally formed with thesecond mesh layer, the tether having a sufficient length to extend fromthe patch and through the abdominal wall defect when the patch is on oneside of the defect, so that a portion of the tether is accessible on theother side of the defect for manipulation from outside a patient's body.2. The implantable prosthesis of claim 1, further comprising a supportmember to support the repair patch in an unfolded configuration.
 3. Theimplantable prosthesis of claim 2, wherein the support member isdisposed on the repair patch.
 4. The implantable prosthesis of claim 2,wherein the at least one tether extends from the patch inward of thesupport member.
 5. The implantable prosthesis of claim 2, wherein therepair patch includes an outer peripheral edge, the support member beinglocated inward of the outer peripheral edge.
 6. The implantableprosthesis of claim 1, wherein the barrier layer is absorbable.
 7. Theimplantable prosthesis of claim 1, wherein the first mesh layer isnon-absorbable.
 8. The implantable prosthesis of claim 1, wherein the atleast one tether includes a pair of tethers integrally formed with thesecond mesh layer.
 9. The implantable prosthesis of claim 8, wherein thesecond mesh layer includes an opening extending therethrough, theopening being located between the pair of tethers.
 10. The implantableprosthesis of claim 9, wherein each tether is located along a side ofthe opening.
 11. The implantable prosthesis of claim 8, wherein thetethers are joined to form a handle that may be grasped and pulled. 12.An implantable prosthesis for repairing an abdominal wall defect, theimplantable prosthesis comprising: a multi-layer soft tissue repairpatch including a first mesh layer, a second mesh layer and an adhesionresistant barrier layer, the first mesh layer located between the secondmesh layer and the barrier layer; and at least one tether extending froma side of the repair patch opposite the barrier layer, the tether havinga width and a thickness with the width varying along a length thereof,the tether having a sufficient length to extend from the patch andthrough the abdominal wall defect when the patch is on one side of thedefect, so that a portion of the tether is accessible on the other sideof the defect for manipulation from outside a patient's body.
 13. Theimplantable prosthesis of claim 12, wherein the tether includes firstand second ends with the first end being joined to the repair patch, thetether being wider at the first end and narrower away from the firstsecond end.
 14. The implantable prosthesis of claim 12, furthercomprising a support member to support the repair patch in an unfoldedconfiguration.
 15. The implantable prosthesis of claim 14, wherein thesupport member is disposed on the repair patch.
 16. The implantableprosthesis of claim 14, wherein the at least one tether extends from thepatch inward of the support member.
 17. The implantable prosthesis ofclaim 16, wherein the repair patch includes an outer peripheral edge,the support member located inward of the outer peripheral edge.
 18. Theimplantable prosthesis of claim 12, wherein the barrier layer isabsorbable.
 19. The implantable prosthesis of claim 12, wherein thefirst mesh layer is non-absorbable.
 20. The implantable prosthesis ofclaim 12, wherein the at least one tether includes a mesh material. 21.The implantable prosthesis of claim 20, wherein the at least one tetherincludes a portion of the second mesh layer.
 22. The implantableprosthesis of claim 21, wherein the at least one tether includes a pairof tethers integrally formed with the second mesh layer.
 23. Theimplantable prosthesis of claim 22, wherein the second mesh layerincludes an opening extending therethrough, the opening being locatedbetween the pair of tethers.
 24. The implantable prosthesis of claim 23,wherein each tether is located along a side of the opening.
 25. Theimplantable prosthesis of claim 22, wherein the tethers are joined toform a handle that may be grasped and pulled.
 26. The implantableprosthesis of claim 20, wherein the at least one tether includes asuture.
 27. An implantable prosthesis for repairing an abdominal walldefect, the implantable prosthesis comprising: a multi-layer soft tissuerepair patch including a first mesh layer, a second mesh layer and anabsorbable barrier layer, the first mesh layer located between thesecond mesh layer and the barrier layer; a support member to support therepair patch in an unfolded configuration; and a pair of tethersextending from a side of the repair patch opposite the barrier layer andinward of the support member, each tether including a portion of meshmaterial that forms the second mesh layer, the tether having asufficient length to extend from the patch and through the abdominalwall defect when the patch is on one side of the defect, so that aportion of the tether is accessible on the other side of the defect formanipulation from outside a patient's body.
 28. The implantableprosthesis of claim 27, wherein the repair patch includes an outerperipheral edge, the support member being located inward of the outerperipheral edge.
 29. The implantable prosthesis of claim 27, wherein thebarrier layer minimizes tissue attachment to the patch.
 30. Theimplantable prosthesis of claim 27, wherein the first mesh layer isnon-absorbable.
 31. The implantable prosthesis of claim 27, wherein thesecond mesh layer includes an opening extending therethrough, theopening being located between the pair of tethers.
 32. The implantableprosthesis of claim 31, wherein each tether is located along a side ofthe opening.
 33. The implantable prosthesis of claim 27, wherein thetethers are joined to form a handle that may be grasped and pulled. 34.The implantable prosthesis of claim 27, wherein the support member isdisposed on the repair patch.
 35. The implantable prosthesis of claim27, wherein each tether includes a suture.
 36. An implantable prosthesisfor repairing an abdominal wall defect, the implantable prosthesiscomprising: a multi-layer soft tissue repair patch including a firstmesh layer, a second mesh layer and an adhesion resistant barrier layer,the first mesh layer located between the second mesh layer and thebarrier layer, the second mesh layer having an opening therethrough; asupport member to support the repair patch in an unfolded configuration;and a pair of tethers extending from a side of the repair patch oppositethe barrier layer and inward of the support member, the tethersextending from spaced apart portions of the repair patch with theopening located therebetween, each tether having a sufficient length toextend from the patch and through the abdominal wall defect when thepatch is on one side of the defect, so that a portion of the tether isaccessible on the other side of the defect for manipulation from outsidea patient's body.
 37. The implantable prosthesis of claim 36, whereinthe repair patch includes an outer peripheral edge, the support memberbeing located inward of the outer peripheral edge.
 38. The implantableprosthesis of claim 36, wherein the barrier layer is absorbable.
 39. Theimplantable prosthesis of claim 36, wherein the first mesh layer isnon-absorbable.
 40. The implantable prosthesis of claim 36, wherein theopening extends across the width of the second layer.
 41. Theimplantable prosthesis of claim 36, wherein each tether is located alonga side of the opening.
 42. The implantable prosthesis of claim 36,wherein the tethers are joined to form a handle that may be grasped andpulled.
 43. The implantable prosthesis of claim 36, wherein each tetherincludes a mesh portion and a suture.
 44. The implantable prosthesis ofclaim 36, wherein the support member is disposed on the repair patch.45. An implantable prosthesis for repairing an abdominal wall defect,the implantable prosthesis comprising: a multi-layer soft tissue repairpatch including a first mesh layer, a second mesh layer and an adhesionresistant barrier layer, the first mesh layer located between the secondmesh layer and the barrier layer; and at least one tether extending froma side of the repair patch opposite the barrier layer, the tetherincluding a mesh portion and a suture portion, the tether having asufficient length to extend from the patch and through the abdominalwall defect when the patch is on one side of the defect, so that aportion of the tether is accessible on the other side of the defect formanipulation from outside a patient's body.
 46. The implantableprosthesis of claim 45, further comprising a support member to supportthe repair patch in an unfolded configuration.
 47. The implantableprosthesis of claim 46, wherein the support member is disposed on therepair patch.
 48. The implantable prosthesis of claim 46, wherein the atleast one tether extends from the patch inward of the support member.49. The implantable prosthesis of claim 48, wherein the repair patchincludes an outer peripheral edge, the support member being locatedinward of the outer peripheral edge.
 50. The implantable prosthesis ofclaim 46, wherein the support member is disposed on the repair patch.51. The implantable prosthesis of claim 45, wherein the barrier layer isabsorbable.
 52. The implantable prosthesis of claim 45, wherein thefirst mesh layer is non-absorbable.
 53. The implantable prosthesis ofclaim 45, wherein the at least one tether includes a pair of tethers.54. The implantable prosthesis of claim 53, wherein the second meshlayer includes an opening extending therethrough, the opening beinglocated between the pair of tethers.
 55. The implantable prosthesis ofclaim 54, wherein each tether is located along a side of the opening.56. The implantable prosthesis of claim 53, wherein the tethers arejoined to form a handle that may be grasped and pulled.